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Cefixime

Generic Name
Cefixime
Brand Names
Suprax
Drug Type
Small Molecule
Chemical Formula
C16H15N5O7S2
CAS Number
79350-37-1
Unique Ingredient Identifier
XZ7BG04GJX

Overview

Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.

Indication

For use in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: (1) uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis, (2) otitis media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella catarrhalis (most of which are beta-lactamase positive), and S. pyogenes, (3) pharyngitis and tonsillitis caused by S. pyogenes, (4) acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains), and (5) uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains).

Associated Conditions

  • Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae
  • Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae
  • Bacterial Sinusitis
  • Community Acquired Pneumonia (CAP)
  • Gonorrhea of anus
  • Lyme Disease
  • Salmonella Infections
  • Shigella Infection
  • Streptococcal Pharyngitis
  • Tonsillitis streptococcal
  • Uncomplicated Urinary Tract Infections
  • Bacterial otitis media
  • Bacterial rhinosinusitis
  • Disease caused by Salmonella typhi
  • Uncomplicated Gonorrhea

Research Report

Published: Sep 4, 2025

Cefixime (DB00671): A Comprehensive Pharmacological and Clinical Monograph

1.0 Executive Summary

1.1 Overview of Cefixime

Cefixime is a semisynthetic, orally active, third-generation cephalosporin antibiotic. Identified by DrugBank Accession Number DB00671 and CAS Number 79350-37-1, it is classified as a small molecule drug.[1] Cefixime exerts a bactericidal effect by inhibiting the synthesis of the bacterial cell wall, a mechanism characteristic of β-lactam antibiotics.[1] Its chemical structure confers stability against many common β-lactamase enzymes, allowing it to maintain efficacy against pathogens that are resistant to penicillins and earlier-generation cephalosporins.[2]

1.2 Key Pharmacological Characteristics

The pharmacokinetic profile of cefixime is notable for its partial oral absorption (30-50%), which is significantly influenced by the pharmaceutical formulation; the oral suspension achieves higher peak concentrations than solid dosage forms.[5] Food delays the time to maximum concentration but does not substantially alter the overall absorption of tablets and suspension.[4] The drug is approximately 65-70% bound to plasma proteins and is distributed to various tissues, including the respiratory and urinary tracts.[5] Critically, cefixime is not metabolized in vivo and is primarily excreted unchanged by the kidneys, with a smaller fraction eliminated through the bile.[4] This reliance on renal clearance mandates dosage adjustments in patients with renal impairment. The elimination half-life averages 3 to 4 hours, which supports convenient once or twice-daily dosing regimens.[7]

1.3 Summary of Clinical Applications and Limitations

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/02
Phase 4
Terminated
Bulovka Hospital
2023/10/19
Phase 4
Completed
Bulovka Hospital
2022/03/24
Phase 2
Recruiting
2022/01/31
Phase 2
Completed
Haiphong University of Medicine and Pharmacy
2021/08/30
Not Applicable
UNKNOWN
2021/07/29
Not Applicable
Completed
2021/07/12
Phase 3
Recruiting
2020/04/16
Phase 4
Recruiting
2019/05/31
Phase 3
UNKNOWN
Post Graduate Institute of Medical Education and Research, Chandigarh
2019/02/15
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Lupin Pharmaceuticals, Inc.
27437-206
ORAL
200 mg in 5 mL
12/15/2023
Lupin Pharmaceuticals, Inc.
27437-201
ORAL
400 mg in 1 1
12/15/2023
Lupin Pharmaceuticals, Inc.
27437-208
ORAL
400 mg in 1 1
12/15/2023
Lupin Pharmaceuticals, Inc.
68180-416
ORAL
400 mg in 1 1
7/11/2025
Aurobindo Pharma Limited
65862-752
ORAL
200 mg in 5 mL
2/14/2024
Lupin Pharmaceuticals, Inc.
68180-423
ORAL
400 mg in 1 1
7/11/2025
Lupin Pharmaceuticals, Inc.
68180-405
ORAL
100 mg in 5 mL
7/11/2025
Aurobindo Pharma Limited
65862-751
ORAL
100 mg in 5 mL
2/14/2024
Ascend Laboratories, LLC
67877-584
ORAL
400 mg in 1 1
11/30/2021
Lupin Pharmaceuticals, Inc.
27437-205
ORAL
200 mg in 1 1
12/15/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SUPRAX
odan laboratories ltd
00868981
Tablet - Oral
400 MG
12/31/1990
SUPRAX
aventis pharma inc
02195984
Tablet - Oral
400 MG
12/31/1990
SUPRAX
odan laboratories ltd
00868965
Powder For Suspension - Oral
100 MG / 5 ML
12/31/1990
SUPRAX
sanofi-aventis canada inc
00868973
Tablet - Oral
200 MG
12/31/1990
AURO-CEFIXIME
auro pharma inc
02432773
Tablet - Oral
400 MG
10/24/2014
SUPRAX
aventis pharma inc
02195992
Powder For Solution - Oral
100 MG / 5 ML
12/31/1990
SUPRAX - TAB 200MG
rhone-poulenc rorer canada inc.
02195976
Tablet - Oral
200 MG / TAB
12/31/1990
AURO-CEFIXIME
auro pharma inc
02468689
Powder For Suspension - Oral
100 MG / 5 ML
1/8/2018

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CEFIXIMA REIWA HEALTHCARE 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Reiwa Healthcare S.L.
88325
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DENVAR 100 MG/5 ML GRANULADO PARA SUSPENSIÓN ORAL
Merck S.L.
59733
GRANULADO PARA SUSPENSIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Commercialized
CEFIXIMA SANDOZ 400 MG CAPSULAS DURAS EFG
Sandoz Farmaceutica S.A.
65856
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DENVAR 400 mg CAPSULAS
Merck S.L.
60469
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized
DENVAR 200 mg CAPSULAS
Merck S.L.
58819
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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